Big Bad Pharma

23 Feb 2012 Vol. 11, No. 2 • Published by VirSci Corp. www.pharmamarketingnews.com www.virsci.com

Big Bad Pharma

How Bad Drug Shortages, Bad Drug Supply Chain, Bad

Manufact uring, Bad Ideas, and Bad Journalism Contribute to Pharma ’s Bad Reputation Author: John Mack

PMN112 -01

Find resources cited this article online at: http://tinyurl.com/5hgxra

This article is part of the February 23, 2012 issue of Pharma Marketing News.

For other articles in this issue, see (after February 29, 2012): http://www.news.pharma-mkting.com/PMNissue112Feb2012archive.htm

Published by: VirSci Corporation PO Box 760 Newtown, PA 18940 [email protected] Pharma Marketing News Vol. 11, No. 2: February 23, 2012 p. 2

he drug industry is contending with a storm of Creating Jobs unsavory media coverage documenting drug This election year every industry is bragging that it has T shortages in the U.S., drug counterfeiting, and the solution for creating jobs and turning the economy recalls due to manufacturing faults. Some say bad around. Every night, during the evening news, we are journalism is heightening the “bad” news while ignoring reminded by the oil industry, for example, that new oil the good that the industry does, which includes creating and gas drilling will create thousands, nay, a million, life-saving drugs and jobs. new jobs in the U.S. “And that’s a good thing,” says the woman in the ads. We Cured Cancer Dammit! With regard to life-saving drugs, there can be little doubt The pharmaceutical industry also reminds Americans that the industry deserves credit, although some drug that it creates jobs. PhRMA, the industry's trade company CEOs overplay the role of the industry and association in the U.S., churns out press releases that that generates bad press. Recently, for example, Marijn warn Americans that if the government passes such- Dekkers, "outspoken" head of Bayer Pharmaceuticals, and-such law or over-regulates such-and-such activity blamed ungrateful patients for not acknowledging of the pharmaceutical industry, it will result in the loss of pharma’s role in “curing” cancer. American jobs. "If you have cancer, you get a pharmaceutical product, In a response to the President's Fiscal Year 2013 and your cancer goes away,” said Dekkers in a Wall Budget, for example, PhRMA stated "America's Street Journal interview. “You're quick to call the doctor biopharmaceutical industry is a key driver of economic and [say] the staff at the hospital was great. But the pill growth; the President's proposed budget would weaken that did it gets forgotten. We struggle with getting our ability to innovate and create jobs. This is not an society to put value on what we do, and it becomes investment in America's future and these proposals particularly important as we get under more pressure to should not be considered" (see "PhRMA Statement on develop the next pill" (for more, see http://bit.ly/zaeakk). the President's Fiscal Year 2013 Budget"; http://bit.ly/zrAbM5). Compare that exaggerated scenario to reality: deaths from cancer, adjusted for the size and age of the pop- Bad Reputation ulation, have changed little since the 1950s, while death However, when Americans were asked "Thinking about rates from heart disease and stroke have dropped sig- the role each of the following sectors played in the cur- nificantly (see Figure 1, below). In this age of social rent state of the American economy, do you think each media amplification of news sound bites and instant of the following sectors is a part of the problem, a part online collaboration, drug company executives— of the solution, or are you unsure?," only 15% said the including CEOs—need to be extra careful about what pharmaceutical industry was part of the solution, ac- they say to reporters. cording to the 2012 Harris Poll Annual RQ survey. Fifty percent (50%) said the industry was part of the problem (see Figure 2, page 3). According to Harris, that puts the drug industry on the cusp of being a "malefactor"— an industry that Americans blame for economic woes. Is Pharma’s Bad Reputation Deserved? “All the companies have to do to figure out why their reputation is in the dirt, is look in the mirror,” said an anonymous commenter to a Pharma Marketing Blog post. That and sentiments like it prompted Pharma Marketing News to ask readers if they believed that drug industry’s reputation was deserved or not. The question was part of the “How to Earn Back the Public's Trust” survey, the results of which were summarized previously (see “Pharma’s Bad Rep or Bad Rap”; http://bit.ly/pmn83-01). While a clear majority of non-industry respondents (ie, HCPs and the general public) said “Yes,” only a small minority of pharma and agency respondents were willing to admit that the bad reputation was deserved Figure 1. A Stubborn Disease. Source: NYT; http://nyti.ms/xkvmN1 Continues…

Figure 2. Industry Part of Economic Solution or Economic Problem. Source: 2012 Harris Poll Annual RQ survey; http://bit.ly/xeJI2T

Figure 3. Question: In general, do you believe the industry's bad reputation is deserved? Source: “How to Earn Back the Public's Trust” survey; http://bit.ly/pmnsurveytrust

(see Figure 3, page 3). “Maybe” was their most popular At the 2010 Annual Public Relations & Communications choice. Among all respondents, 98% who are unsup- Summit at Pfizer Headquarters in NYC, Chris Loder, portive of the industry said “Yes,” whereas only 28% of Pfizer's Head of US Media Relations, cited World supportive respondents agreed. Health Organization data that says 1% of worldwide sales of Rx drugs are counterfeit. Loder claimed that Of course, the drug industry can be both part of the number is between 10 and 50 percent in "developing" solution and part of the problem. It depends on whose nations. Pfizer defines counterfeit as "products delib- problem/solution you are talking about. erately and fraudulently produced and/or mislabeled Pharma is part of the solution for white-collar workers with respect to identity and/or source to make it appear who work within industry, have Rx medical coverage, to be a genuine product." and can afford prescription drug co-pays. Blue-collar Loder spoke of Pfizer's all out campaign to bring atten- workers and retired folk who depend more on govern- tion to the counterfeit drug problem, which obviously ment "safety nets," however, may see high drug prices hurts sales, especially of Pfizer's flagship drug, Viagra. and the drug industry's antipathy toward Medicare re- But it’s also a safety issue: "Counterfeit medicines are a bates as part of the problem. The latter are not among risk to patient health and safety," said Loder. "That's the the typical U.S. pharma work force especially as the one message we send." drug industry ships more and more blue-collar manufacturing jobs overseas to countries like China. Drug Supply Chain Safety PhRMA maintains that “the most common means for

counterfeit drugs to enter the United States is through purchases made on illegal online pharmacy websites Outsourcing Will Grow operated by criminals in countries that have known counterfeiting problems” (see http://bit.ly/w3EFZN). Over 75% of respondents to the PMN “Predicting the Future of the Drug Industry Yet according to Allan Coukell, director of the Pew Survey” agree with the statement: Charitable Trusts’ medical group, counterfeit Avastin “isn’t something that was ordered over the Internet, or “Pharmaceutical and biotech companies will sold on a street corner. It illustrates that it’s possible to continue to increase their outsourcing of clinical sell a fake drug into a legitimate distribution system.” trials and related drug development. Outsourc- ing will account for more than 50% of R&D Coukell was quoted group in a recent Washington spending by 2019.” Journal article (http://wapo.st/wJb5MI). Learn more about this survey and the results While there are no known cases of someone being here: http://bit.ly/PMNsurveyPredict poisoned by counterfeit Viagra, it is a certainty that Americans died from a tainted drug entering the supply chain via legitimate means. In 2007 and 2008, for example, “up to 149 Americans died … after taking Drug Counterfeiting heparin, a blood thinner, contaminated during the It can be argued that by exporting drug manufacturing— manufacturing process in China," according to a "Drug and also clinical trials—to countries like India and Safety and Accountability" bill in (re)introduced in China, the U.S. pharmaceutical industry also endangers Congress in 2011. Also according to that bill, “up to 80 our drug supply. This link between overseas drug percent of the active ingredients in drugs used in the manufacturing and counterfeit or tainted drugs in the United States are made overseas, many in countries U.S. was suggested in a recent news story about where regulatory oversight does not meet the standards counterfeit Avastin: of the United States.” "Most Americans don't question the integrity of the It wasn't the active ingredient in Heparin that caused the drugs they rely on. They view drug counterfeiting, if they problem, it was a contaminant that was deliberately are aware of it at all, as a problem for developing added to heparin batches that were processed in China countries. But the latest incident, which follows the from pig's intestines by the American pharmaceutical appearance of other fake drugs in the U.S.—including firm Scientific Protein Laboratories. The contaminant counterfeits of the weight-loss treatment Alli and the mimics the in-vitro properties of heparin, but is much influenza treatment Tamiflu—suggests it is a growing cheaper than heparin, which is obtained from pig intes- risk, especially as more medicines and drug ingredients tine. It seems that there was a shortage of pigs in China sold in the U.S. are made overseas (see "Roche warns at the time, perhaps due to efforts to curtail swine flu. of fake cancer drug in US"; http://bit.ly/zI5lUb). Continues…

Figure 4: How Fake Avastin Entered U.S. Drug Supply Chain

Figure 5: Counterfeit Drug Incidents. Top: yearly totals of counterfeit drug “incidents” logged by the Pharmaceutical Security Institute (PSI). Bottom: geographical distribution of incidents in 2010.

So, yes, counterfeiting was the problem, but not coun- were divided about the adequacy of the government’s terfeiting done by renegade "bad guys" selling product effort to secure the safety of drugs produced in the through the Internet, which Loder focused on as the U.S.; 42% said the government should do more, main problem. It was contamination at the facility re- whereas 45% said the government is doing the right sponsible for producing product for sale in the US. And amount. the product found its way into the normal drug supply chain unnoticed by regulatory authorities. A Washington Post article noted that “For more than a decade, public safety advocates have called for a tracking system that would enable everyone from manufacturers to wholesalers to doctors to verify the authen- ticity of prescription drugs through electronic tags or barcodes. But bickering between those parties over the cost and scope has stalled the effort.” In response to a letter from U.S. Senator Michael Bennet (D-CO) pushing for the FDA to consider a uniform pedigree standard as a component of a compre- hensive solution to drug safety and drug shortage problems, the FDA said: Figure 6. Confidence in Countries on RX Safety. Source: Pew “We agree that implementation of a uniform pedigree or Prescription Project poll, April 2010. track-and-trace system may help further secure the integrity of the drug supply chain by providing trans- Perhaps the poll did not tell respondents that up to 80 parent and accurate information on the origin, source, percent of the active ingredients in drugs used in the and handling of a drug throughout the supply chain,” United States are made overseas. Jeanne Ireland, assistant commissioner for legislation, wrote in the letter. “…A robust track-and-trace system The story about how drug companies may or may not may help protect consumers from threats posed by be monitoring the drug pipeline for adulterated— illegal or substandard products, which may result from a counterfeit or not—products is NOT being told. Perhaps drug shortage situation, in addition to providing this is because the PR people cannot think of dramatic accountability and transparency of the supply chain.” images such as dead rats and sleazy criminals to represent the problem with drug supply chains. Or PhRMA, however, continues to insist that the U.S. drug perhaps focusing on the supply chain hits too close to supply chain is “one of the most secure supply chains in home. the world” (http://bit.ly/xbue2B). Although PhRMA says it is committed “to work with … private partners and Drug Shortages government officials on ways to prevent diverted and Also in the news lately is the nation’s shortage of life- counterfeit medicines from being introduced into the saving drugs such as methotrexate, a drug used to treat legitimate supply chain,” it has been silent regarding children's leukemia among other maladies. In a letter to implementing a tracking system that has helped other Congressman Carney, author of H.R.3839 (“Drug Shor- countries develop an even more secure system than tage Prevention Act of 2012”), the American Society of exists in the U.S. Health-System Pharmacists (ASHP) said “prescription drug shortages have created a public health crisis forc- Americans’ Attitude Regarding Drug Safety ing clinicians to scramble to find life-saving medications Aside from counterfeiting being a risk to public health, for their patients.” another message that consumers should be getting is that the drug supply chain can also be a risk to patient As reported in the Chicago Tribune, "the FDA says the health and safety. Yet, they may not be getting that main reason for the shortages is manufacturing de- message. ficiencies leading to production shutdowns. Shortages also are resulting from companies halting production of According to a Pew Prescription Project poll drugs with low profit margins, companies consolidating ("American's Attitudes on Prescription Drug Safety"), in the generic drug industry and supplies of some Americans are confident that drugs produced and sold ingredients shrinking" (see http://trib.in/zOjhwe). in the US are safe, but those produced in China and India are not (see Figure 6, above right). American’s Continues…

"This dramatic rise in the extent, duration and severity • @Novartis: "Novartis continues to research ways to of shortages is occurring in an environment that is control tumor growth in advanced #breastcancer" characterized by a near absence of communication The Rx drug industry is betting its future on developing between drug manufacturers and the Food and Drug complex biologics to treat major diseases such as Administration (FDA),” said the ASHP in an article titled cancer. If the current crisis is any indication about how “Can the United States Ensure an Adequate Supply of successful they will be in (1) manufacturing biologics Critical Medications?” (find it here: http://bit.ly/Avguk1). and (2) using social media to inform the public about “This lack of transparency is a significant barrier to the products and support patients who depend on these efforts to address drug shortages, and it represents a products, then, it is not likely that they will succeed. real and growing danger to patient safety. FDA has Bad Journalism or Bad Pharma? worked diligently to address this issue, but this work is All this bad news about the pharmaceutical industry hampered by the agency’s inability to require reporting could be blamed on bad journalism, which was a topic of information that could be instrumental in minimizing addressed Rich Meyer on World of DTC Marketing the impact of a shortage or averting it all together." Blog. Meyer went on a bit of a rant against "bad Lack of Patient Support Via Social Media journalism" and how pharma is often misrepresented in Not only is there a “lack of communication” between the news media (see "Bad journalism paints unfair drug manufacturers and the FDA, there is a lack of picture of pharma industry"; http://bit.ly/yrIvJa). communication between drug companies and their The drug industry has consistently blamed the news patients regarding this issue. That leads to more bad media for painting an "unfair picture" (see, eg, Figure 7, press and adds to the industry’s bad rep. below). The news media, however, more often than not Twitter and other social media publishes “good” news about the industry and often can be effective in supporting reporters merely quote verbatim from drug company patients when there is a problem press releases (see, for example, "The Cymbalta Buzz with drugs (see, for example, Machine is at Full Throttle!"; http://bit.ly/xtlfir). “Use of Twitter for Patient Support”; http://bit.ly/pmn92-01). Yet the pharmaceutical industry has not been very pro-active in reaching out to support patients via social media. Despite using social media to push out positive news about their companies and products, pharmaceutical companies whose products are in short supply have not used these channels to commun- icate with patients. Boehringer and Novartis—which own companies whose CEOs received letters from various cancer groups pleading for help alleviating the drug shortage caused by their troubled manufacturing processes—have posted positive tweets about their commitment to cancer patients, while completely ignoring the cancer drug shortage issue. Here are some recent (February 2012) tweets:

• @BoehringerUS: "@WHO estimates that 84 million people will die of cancer between 2005 and 2015 without intervention. #WorldCancerDay" Figure 7. Media Focus on Bad News is a Cause of Drug Industry’s • @Boehringer: "@martin_dudziak Very true. We are Bad Rep. Percent of survey respondents who agree. Source: “How also committed and believe in continued research & to Earn Back the Public's Trust” survey; http://bit.ly/pmnsurveytrust clin trials as a major key factor in fighting cancer!" • @MylanNews: "Mylan Committed to Expanding Access to High Quality, Affordable #HIV/AIDS Continues… Treatment. Company Honors #WorldAIDSDay"

In a more recent example of how pliant the news media Only 51% of survey respondents agreed strongly or often are, Boehringer Ingelheim (BI) was chastised by somewhat (63% of pharma respondents agreed; see the British Prescription Medicines Code of Practice Figure 7, page 7). While that was a majority, even more Authority (PMCPA) for distributing a press release and respondents agreed that other issues are at fault: such briefing material for spokespersons that would in effect as "lack of transparency regarding negative clinical encourage members of the public to ask their health data" (81% agree) and "high costs of prescription professional to prescribe a specific prescription only drugs" (81% agree). medicine. In fact, several news articles went even Meanwhile, in an FCC Journalism Report, "complaints further and made some great marketing statements that abound from seasoned reporters who lament the BI could never make, such as referring to Pradaxa as a growth of 'press release reporting' and the lack of time "super pill" and a "revolutionary drug." The stories also they have to check out the veracity of information dissed the competition (warfarin) by referring to it as "rat contained in a press release. Twenty eight percent of poison" (see "BI Masters the Art of WOM through Its health reporters said that they personally get story ‘Parrots,’ er, Spokespersons"; http://bit.ly/zLSsOm). ideas from public relations firms or marketing outreach These are news stories about pharma products and not somewhat or very often" (see "New FCC Journalism about the pharmaceutical industry itself, which is what Report Paints Bleak Picture of Health Coverage"; Meyer was focused on. Getting news media to publish http://bit.ly/xykkAS). positive stories about products is very important to A March 2009 Survey of American Health Care pharmaceutical companies. As for stories about the Journalists (AHCJ) found that just under half (44%) of industry itself, well that's why there exists the PhRMA staff journalists participating in the survey say that their trade association, which counterbalances negative organization sometimes (34%) or frequently (10%) stories in the press and competes with news media to bases stories on news releases without substantial influence lawmakers. PhRMA has a tremendous budget additional reporting (see "Academics Exaggerate, and the industry shouldn't worry too much about the Journalists Regurgitate. What About Bloggers?"; sort of "bad press" Rich is talking about, IMHO. http://bit.ly/zcokYK). Is News Media to Blame? IMHO, this is "bad journalism," but of a type that tends Some time ago, Pharma Marketing hosted the survey to paint a more rosy picture of the pharmaceutical "How to Earn Back the Public's Trust," which asked industry and the good it does. respondents if they agreed that the press is the main culprit for pharma's bad public image because news Pharma Marketing News media report mostly bad news about the industry and not the good that it does. Pharma Marketing News Pharma Marketing News is an independent, free electronic newsletter focused on issues of importance to pharmaceutical marketing executives. Subscribe Online • Download Media Kit • Request a Rate Card